Phase 1 Trial of KH617

NCT05667194 | Recruiting Phase 1

• 1 other identifier: KH617
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

KH617 is a injection used for advanced solid tumors which must be diluted with 5% Dextrose Injection.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• MTD

  90 weeks

• DLT

  90 weeks

• RP2D

  154 weeks

Secondary Outcomes (2)

• ORR

  154 weeks

• PFS

  154 weeks

Study Arms (5)

KH617 dose 1

EXPERIMENTAL

Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle

Drug: KH617

KH617 dose 2

EXPERIMENTAL

Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle

Drug: KH617

KH617 dose 3

EXPERIMENTAL

Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle

Drug: KH617

KH617 dose 4

EXPERIMENTAL

Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle

Drug: KH617

KH617 dose 5

EXPERIMENTAL

Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle

Drug: KH617

Interventions

KH617 DRUG

KH617 is s freeze-dried powder injection

KH617 dose 1; KH617 dose 2; KH617 dose 3; KH617 dose 4; KH617 dose 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
• Patient is male or female ≥18 years of age. 3.Patient must satisfy the following laboratory test results:
• a.Hemoglobin ≥9g/dL b.Platelet count ≥100×10\^9/L c.Absolute neutrophil count≥1.5×10\^9/L d.Albumin ≥3.0g/dL e.Total bilirubin ≤1.5×ULN f.Aspartate aminotransferase and alanine aminotransferase≤2.5×ULN g.Adequate renal function, defined as estimated serum creatinine clearance\>50mL/minute calculated using the Cockcroft-Gault equation,urine protein\<2+ or urine protein\>2+ but 24-hour proteinuria\<1g h.Prothrombin time, international normalized ratio, and activated partial thromboplastin time≤1.5×ULN (except for patients receiving anticoagulant therapy) 4.Patients who have fully recovered (defined as ≤grade 1 NCI-CTCAE 5.0) from all previous acute treatment-related toxic effects of previous cancer treatments prior to enrollment.
• Advanced Solid Tumors
• Patients with histopathology and/or cytology diagnosed as unresectable, locally advanced or metastatic malignant solid tumors for which there is no further standard treatment or for which the patient is not tolerated.
• Patient has at least one measurable or evaluable target lesion by RECIST 1.1.
• Patient has an ECOG status of 0 to 2.
• Brain Metastases
• Patient has at least one measurable or evaluable target lesion by RANO-BM.
• rGBM
• Patient with histopathology and/or cytology diagnosed advanced malignant adult diffuse glioma has unequivocal evidence of GBM recurrence/progression following completion of standard treatment.
• Patient has at measurable or evaluable target lesion by RANO.
• Patient has a Karnofsky Performance score (KPS) ≥60.

You may not qualify if:

• Patient has received extensive radiation therapy. 2.Patients has the following infectious diseases:
• a.Hepatitis B surface antigen-positive and HBV-DNA test indicated active hepatitis B b.Active hepatitis c. C. AIDS or HIV antibody test is positive. d.Uncontrolled active infection. 3. Patient has a positive blood beta-HCG pregnancy test 7 days before the first administration (only for female with bearing potential ), or male and female with bearing potential who are unwilling to use adequate contraception for the duration of the study, and for a minimum of6 months after last dose of KH617.
• \. 11.Patient is currently pregnant or breastfeeding. 5. Patients with previous phrenoblabia history or currently phrenoblabia Including but not limited to schizophrenia, paranoia, phobias, obsessive-compulsive disorder, insomnia, Alzheimer's disease, behavioral volitional disorder, postpartum mental disorder, paranoid mental disorder, or organic psychosis.
• \. Patient has had another malignancy within the previous 5 years. 7. Patient has active cardiac or cerebrovascular disease. 8.Patient has participated in another investigational study using an investigational or marketed drug or device within 28 days.

Sponsors & Collaborators

• Sichuan Honghe Biotechnology Co., Ltd.: lead

Study Sites (1)

Beijing Titan Hospital,Capital Medical University

Beijing, Beijing Municipality, 100000, China

RECRUITING

Study Officials

• Wenbin Li

  Beijing Titan Hospital,Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhao Manxi

CONTACT

86 15882459305; zhaomanqian@cnkh.com

Ziyun Gan

CONTACT

86 15520826510; 020735@cnkh.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: December 28, 2022
• Study Start: December 26, 2022
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): August 1, 2031
• Last Updated: November 27, 2024

Record last verified: 2024-03

Locations

CN (1)